Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)

Sponsor
Annie C Lajoie (Other)
Overall Status
Completed
CT.gov ID
NCT03455920
Collaborator
Laval University (Other)
200
1
2
28.4
7.1

Study Details

Study Description

Brief Summary

Sleep apnea is a prevalent problem and references for the evaluation of this condition often exceeds the sleep clinic's capacity thus creating important delays in the patients' care.

The overall goal of this project is to assess the feasibility and the non-inferiority of integrating a clinical nurse, or supernurse, to the initial consultation team.

The hypothesis is that the integration of a clinical nurse to the sleep clinic's evaluation team is non inferior in terms of patients' outcomes such as improvement of symptoms and quality of life as well as adherence to treatment.

This study is supported by funding dedicated to teaching and research activities related to sleep-disordered breathing.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical nurse (supernurse) evaluation
  • Other: Pulmonologist evaluation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
Actual Study Start Date :
Dec 19, 2017
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multidisciplinary arm

Patients randomized in this group will have their first sleep clinic evaluation with the clinical nurse. She will then discuss each case with the pulmonologist and validate the diagnostic and therapeutic avenue.

Other: Clinical nurse (supernurse) evaluation
The first evaluation of the patient refered to the sleep clinic will be performed by the clinical nurse then discussed with the pulmonologist in charge.

Active Comparator: Pulmonologist arm

Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.

Other: Pulmonologist evaluation
The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.

Outcome Measures

Primary Outcome Measures

  1. Improvement in symptoms [Assessed at three months]

    Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)

  2. Improvement in symptoms [Assessed at six months]

    Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)

Secondary Outcome Measures

  1. Improvement in quality of life [Assessed at three months]

    Based on the Quebec Sleep questionnaire

  2. Improvement in quality of life [Assessed at six months]

    Based on the Quebec Sleep Questionnaire

  3. Positive pressure treatment adherence [Assessed at six months]

    Number of hours used per night according to CPAP report

  4. Mandibular advancement device treatment adherence [Assessed at six months]

    According to the patient's usage report

  5. Weight loss treatment adherence [Assessed at six months]

    Changes from baseline weight (kg)

  6. Positional therapy [Assessed at six months]

    Proportion of time spent supine at baseline and at control cardio-respiratory recording

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients referred to the ''Institut Universitaire de Cardiologie et Pneumologie de Québec'' 's sleep clinic who have undergone a cardiorespiratory polygraphy.

  • Body mass index (BMI) between 27-35 kg/m2;

  • Apnea-Hypopnea Index (ADI) equal or above 20 events per hour with less than 5 events per hour of central origin;

  • Oxygen Desaturaton Index (ODI) equal or above 10 events per hour;

  • Percentage of time spent below 90% of oxygen saturation equal or less than 10%

Exclusion criteria :
  • Patients not meeting the above inclusion criteria.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ) Quebec City Quebec Canada G1V4G5

Sponsors and Collaborators

  • Annie C Lajoie
  • Laval University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Annie C Lajoie, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier:
NCT03455920
Other Study ID Numbers:
  • Sleep Apnea Supernurse
First Posted:
Mar 7, 2018
Last Update Posted:
Dec 10, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2020